| CTRI Number |
CTRI/2021/09/036396 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
15/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Transcutaneous electrical nerve stimulation on pain, Breathing capacity and cough in patients undergone coronary artery bypass grafting surgery |
|
Scientific Title of Study
|
Effect of Transcutaneous electrical nerve stimulation on pain,inspiratory capacity and cough in patients undergone median sternotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apurva Bhimsing Pardeshi |
| Designation |
Masters in cardiorespiratory physiotherapy |
| Affiliation |
Sancheti College Of Physiotherapy |
| Address |
Sancheti College Of Physiotherapy
11/12, Thube Park, Shivajinagar, Pune, Maharashtra 411005
11/12, Thube Park, Shivajinagar, Pune, Maharashtra 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9892215655 |
| Fax |
|
| Email |
pardeshi.apurva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajakta Sahasrabuddhe |
| Designation |
Associate Professor Department of Cardio-respiratory physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti College Of Physiotherapy
11/12, Thube Park, Shivajinagar, Pune, Maharashtra 411005
Sancheti College Of Physiotherapy
11/12, Thube Park, Shivajinagar, Pune, Maharashtra 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9930677920 |
| Fax |
|
| Email |
prajakta.sahasrabudhe2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajakta Sahasrabuddhe |
| Designation |
Associate Professor Department of Cardio-respiratory physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti College Of Physiotherapy
11/12, Thube Park, Shivajinagar, Pune, Maharashtra 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9930677920 |
| Fax |
|
| Email |
prajakta.sahasrabudhe2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, 12, Thube Park, Shivajinagar Pune-411005 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apurva Pardeshi |
Sancheti Hospital-Institute for Orthopaedic and Rehabilitation |
Department of Cardio-respiratory physiotherapy
Pune
MAHARASHTRA |
9892215655
pardeshi.apurva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteeSanchetiInstituteforOrthopaedicsandRehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Transcutaneous electrical nerve stimulation |
Placebo Transcutaneous electrical nerve stimulation shall be given to patients for 5days from Postoperative day1-day5 for 30mins/session |
| Intervention |
Transcutaneous electrical nerve stimulation |
Transcutaneous electrical nerve stimulation shall be given for 5days from Postoperative day1-day5 for 30mins/session |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Hemodynamically stable patients
2.GCS more than 13
3.Patients extubated withing 24 hours |
|
| ExclusionCriteria |
| Details |
1.Intubated patients
2.Any skin infection
3.High grade fever
4.Pacemaker
5.Patients having sternal instability , persistent angina |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Inspiratorycapacity and Cough SCORE |
Baseline and Day-5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
0 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2021 |
| Date of Study Completion (India) |
31/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised controlled trial that studies the effect of Transcutaneous electrical nerve stimulation on pain, inspiratory capacity and cough in patients undergone median sternotomy.The intervention group shall receive tens from postoperative day1-day5 30mins/session,the non intervention group shall receive Placebo tens for 5days for 30mins/session. The primary outcome measure PICscore shall be recorded on day 0of intervention and day 5 of intervention respectively. This will be followed by statistical analysis. |